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Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS that have more than one drug product but are not Shared System REMS will not display the product name and ingredient properly on this website due to database limitations. Please refer to the REMS document for the correct product names.

Thalomid (thalidomide)
NDA #020785
REMS last update: 03/24/2023



What is the purpose of the REMS?

The goals of the THALOMID REMS are as follows:

  1. To prevent the risk of embryo-fetal exposure to THALOMID.
  2. To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for THALOMID.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
03/24/2023 Modified to reflect transfer of application ownership from Celgene to Bristol-Myers Squibb Company (BMS), removing the Celgene logo and references to Celgene, and includes updates (e.g., changes to contact department names). The modification also consists of editorial changes to the REMS website, and changing the address of the REMS web portal.
08/05/2021 Modified to:
  • remove the mobile app for physicians
  • include the Patient REMS Application
  • clarify language regarding the question for prescribers about days of therapy being prescribed
  • add new language for reporting pregnancies
  • change the disclosure language on the Patient-Physician Agreement Forms (PPAFs)
  • add new election checkbox on the PPAFs for patients to request Thalomid REMS education materials
06/27/2017 Modified to:

  1. Remove reference to the previous REMS program names.
  2. Remove the CD-ROM/desktop software as a method to enroll patients into the REMS.
  3. Add clarifying language regarding contraception use requirements for contraception use by patients enrolled in the REMS.
  4. Update the name of the Veterans Health Administration in the REMS document and the material.
  5. Add a tear-off quick reference guide for prescribers in the REMS at a Glance appended material.
  6. Add REMS contraception information for patients to be used by non-prescribing healthcare providers.
  7. Add an updated brochure regarding emergency contraception.
06/09/2017 Modified to remove reference to the previous names of the REMS from REMS documents, remove the CD-ROM/desktop software as avenues to enroll patients into the REMS, add clarifying language regarding contraception use within the REMS, update the name of the Veterans Health Administration, add a tear-off quick reference guide for prescribers, add a REMS contraception information piece for patients to use with non-prescribing healthcare providers, introduce a revised protocol for obtaining pregnancy exposure information within the pregnancy registry, remove language related to the launch of the REMS mobile app from the REMS Supporting Document, remove reference from the REMS Supporting Document to an informational webinar that occurred in the past, include language in the REMS Supporting Document regarding the assessment that must accompany efficacy supplements, and include an updated brochure regarding emergency contraception to the approved risk evaluation and mitigation strategy (REMS).
04/22/2016 Modified to change the contact information for emergency contraception information, add flow charts to the Prescriber Guide and the Patient Guide for clarity, add clarifying language to the prescriber enrollment forms about the authorization number, add unacceptable forms of birth control to the Education and Counseling Checklist and Patient Prescriber Agreement Forms (PPAFs), replace “doctor” with “healthcare provider” throughout the PPAF, change the trademark symbols to registered trademark symbols, and insert a “Forgot Password” screenshot in the Celgene Risk Management Website User Guide.
12/01/2015 Modified to add links to Spanish language REMS materials to the REMS website, add additional links from CelgeneRiskManagement.com to the individual product REMS websites, add functionality to the Prescriber Calendar, Review Authorization, and Reports in the prescriber portal in CelgeneRiskManagement.com.
10/27/2015 Modified to remove the ICD-10 code from the Patient Prescription Forms (General Patient Prescription Form and Veterans Administration Patient Prescription Form).
09/13/2015 Modified to:

  1. Include a mobile applications to provide an additional platform to accomplish internet-capable REMS activities in the REMS materials.
  2. Revise a timetable for submission of assessments.
09/12/2014 Modified to:

  1. Remove the “Rules for Dispensing” section in the Education and Counseling Checklist for Pharmacies.
  2. Update the current International Statistical Classification of Diseases and Related Health Problems (ICD) classifications in the Patient Prescription Forms.
11/15/2013 Modified to:

  1. Harmonize the REMS with Revlimid (lenalidomide), and Pomalyst (pomalidomide) capsules.
  2. Add and implement a pharmacy portal to facilitate pharmacy activity within the REMS.
  3. Dispense Thalomid (thalidomide) through certified pharmacies
  4. Harmonize the training that pharmacists receive to dispense Thalomid (thalidomide) capsules with the training pharmacists receive for Revlimid (lenalidomide) and Pomalyst (pomalidomide) capsules.
02/08/2013 Modified to:

  1. Eliminate the requirement for the Medication Guide as an element of the REMS.
  2. Harmonize the REMS programs for Revlimid (lenalidomide) capsules and Thalomid (thalidomide) capsules.
08/03/2010 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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